therapeutic option for hepatitis b and c: a french cohort

Conditions: Viral Hepatitis B; Viral Hepatitis C

Summary: * the cohort will integrate clinical, genetic, pharmacogenomics, environmental, biomarkers and behavioral data in a large number of patients and will be a leading equipment for crossdisciplinary and translational research on hepatitis. * the cohort will be the main support for estimating the relative effects of treatments and for further cost-effectiveness studies on the management and treatment options in chronic hcv (hepatitis c virus)and hbv (hepatitis b virus)infections.

general schedule of the study : * prospective multicenter national study * duration of inclusions:3 years * effective : 25000 patients * duration of the follow-up: 7-8 years * duration of the cohort: 10 years population : twenty-five thousands of people will be included and followed in investigator sites, 15000 with an hepatitis c and 10000 with an hepatitis b, according their usual follow-up of their liver disease. we aim to include up to 50% patients naive of any hcv treatment at inclusion. also hbv "cured" patients could be included (less than 10%). design study: * during the recruitment visit, demographics, clinical, biological and virological data will be collected. the patient will move through several assessments involving questionnaires, measurements and blood sampling. * then the minimum follow-up is one medical visit per year. the follow-up (clinical data and biological collections) will be driven by events or based on protocols that will be developed on the cohort. * there is no specific treatment in this cohort. the scientific project is structured into 4 scientific thematic axes : * therapeutics: * to analyze the long term effects of therapy * to study predictors of virological response or fibrosis progression (or regression)and pharmacokinetic/pharmacodynamics either in hcv or hbv treatments * virology: * to understand the molecular mechanisms of antiviral treatment success and failure * to provide treatment recommendation to prevent resistance and achieve sustained or definitive control of infection * pathology and physiopathology : * to identify new pathophysiological targets responsible for chronic hepatitis severity,prognosis, and evolution. * to validate new therapeutic combinations based on pathophysiological researches * public health: * to identify psychosocial and behavioral correlates of access to care, progression of liver disease and of the burden of chronic viral hepatitis b and c. * to evaluate the cost-effectiveness of hbv and hcv treatments and quality of life

Eligibility criteria:
inclusion criteria: * hbv-positive patients * chronic hepatitis b defined by a positive hbsag ( surface antigen of the hepatitis b virus) for at least 6 months * acute hepatitis b defined as a recent appearance (\<6 months) of detectable hbs ag, * chronic hepatitis b with serological remission hbsag-negative , hb dna-negative, * with or without association with acute or chronic hepatitis d. * hcv-positive patients * chronic hepatitis c defined by the positivity for anti-hcv antibodies for at least 6 months and positive hcv-rna * acute hepatitis c defined by the recent appearance of hcv rna (less than 6 months) in patients with risk factors (with or without positive antibodies) * patients with cured hepatitis c defined by long-term eradication, either spontaneous, a positive anti-hcv antibodies associated to a negative rna at two collection - 6 months interval time; either treatment defined by negative viremia 3 month after end of treatment. exclusion criteria: * hiv co-infected patients are not eligible to the cohort. * so-called vulnerable populations (minors, people under guardianship or protection, or a private individual under protection from making legal or administrative decisions) * treatment ongoing hepatitis c during or stopped since less than 3 months * patients end of life * woman whose pregnancy is known

Keywords: hepatitis b and c anrs hepather french cohort